The microbiome is the more than 100 trillion microorganisms that live in our gut, mouth, skin and other mucosal surfaces of our bodies. These microbes have numerous beneficial functions relevant to supporting life, such as digesting food, preventing disease-causing pathogens from invading the body, and synthesizing essential nutrients and vitamins. With the advancement of genomic technologies, the capacity of the microbiome to influence health and disease can now be harnessed.

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Regulatory Engagement

Photo Credit:  ms.akr

In late 2015, scores of leading scientists urged the creation of a major global initiative to better understand the microbial communities critical to human health and wellness. The proposal has put a global spotlight on the microbiome field but, in order to ensure the benefits of this new field are fully realized, this new approach must be fostered and applied within a carefully constructed regulatory and reimbursement environment. 

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Science Policy


Reaping the benefits of microbiome-based therapeutics, diagnostics and other treatment modalities depends on applying a set of consistent, standardized practices to ensure conformity between and across researchers and companies. At present, there are no widely agreed upon and accepted standards or best practices for sample collection and handling, collation of reference databases, or data collection and manipulation.   

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